Clinical trial

Comparison of Epidural Analgesia With Bilateral Dual TAP Infiltration Block With Liposomal Bupivacaine in Patients With Major Abdominal Surgery

Name

0287-13-FB

Description

This study will compare the infiltrative transversusabdominis plane (TAP) block with liposomal bupivacaine to epidural analgesia (EA) in major abdominal surgery . The efficacy of the TAP block for abdominal surgery is well documented in literature, but there are no studies utilizing long-acting bupivacaine. The investigators believe the study will demonstrate no difference between the two in terms of pain scores and opioid consumption, but TAP blocks will decreased costs, urinary retention, and hypotension.

Trial arms

Trial start

2014-02-01

Estimated PCD

2016-12-01

Trial end

2016-12-01

Status

Completed

Treatment

Epidural

The skin will be disinfected with 2% chlorhexidine. Under sterile technique, the epidural will be placed. Epidural catheter will be placed at thoracic vertebral levels T5 to T10. Level chosen as clinically indicated. The epidural solution should contain institution's standard solution of Bupivicaine 0.05% and hydromorphone 10 mcg/cc. However, solution type should be clinically indicated.

Arms:

Epidural

Other names:

local anesthetic

TAP Block

The skin will be disinfected with 2% chlorhexidine. The bilateral dual TAP infiltrative blocks will be placed using high-frequency ultrasound. The TAP blocks will be performed using lipospheric bupivacaine (Exparel) with the following dosing regimen.A 266mg (20cc) vial of lipospheric bupivacaine will be equally into 2 30 ml syringes using strict sterile technique. The solution will be diluted in each syringe with 20cc preservative free sterile 0.9% normal saline to a total volume of 30 ml in each syringe. Once the transversus abdominal plane is identified then a 5-10 ml of plain 0.9% normal saline will be injected to open the fascial plane. Once the plane is opened then the 15cc of diluted lipospheric bupivacaine will be administered under direct ultrasound visualization in all 4 TAP quadrants (subcostal position x2 and lateral position x2)

Arms:

TAP Block

Other names:

transversus abdominis plane, abdominal muscle anesthesia

Size

Primary endpoint

Pain scores

96 hours post-op

Opioid Consumption in a 24-Hour period

96 hours post-op

Eligibility criteria

Inclusion Criteria: * subject \>/= 19 years of age * Undergoing major abdominal surgery * able to provide written informed consent Exclusion Criteria: * chronic opioid use * allergies to amide anesthetics * inability to undergo general anesthesia * pregnancy * any existence of contraindications to regional anesthesia in the presence of antiplatelet or anticoagulative drugs * or evidence of gross neurological dysfunction of the lower extremity

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'OTHER', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 72, 'type': 'ACTUAL'}}

Updated at

2023-11-28

1 organization

Organization

University of Nebraska